Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Friday, March 30, 2007

Two recent health care research articles and their accompanying editorials once again question the premises which undergird the currently fashionable pay-for-performance (P4P) movement.

We have posted skeptically here, here, and here about P4P. Briefly, our concerns were that P4P could lead to perverse incentives (by rewarding apparently better rates of good outcomes which could be created by avoiding the sickest patients, or emphasizing a few measured processes and thus distracting physicians from doing anything else, or being based on inaccurate or irrelevant data), could emphasize cost cutting over quality, and could emphasize processes which have been better studied, potentially penalizing the specialties that did the most research about quality.

Rapid Antibiotic Treatment for Patients with Pneumonia

The first article(1), currently only available online, addressed a performance measure already in wide use, whether patients with a provisional diagnosis of community-acquired pneumonia receive an antibiotic within four hours of hospital arrival. This is a core quality of measure per the Center for Medicare and Medicaid Services (CMS) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The University HealthSystem Consortium's goal is 90% achievement of this measure. The authors' hospital already bases physician payments on the achievement of this measure.

Fee and Weber constructed a retrospective cohort of patients eligible for this measure according to JCAHO and CMS standards. They then examined the 34.9% of them who failed to meet the standard, i.e., failed to get antibiotics within four hours. They found that 58.5% in turn of these outliers, or 20.4% of the total patient cohort, had not been diagnosed with community acquired pneumonia at the time they left the Emergency Department (ED). Thus the performance measure for treatment of pneumonia was being applied to patients who did not clearly have pneumonia at the time the treatment decisions had to be made.

The accompanying editorial(2) noted many problems with the "four hour rule," in part based on this data. Most important is that the diagnosis of pneumonia is not always obvious in patients presenting to the ED. Yet the four hour rule standard as currently applied requires physicians to give antibiotics promptly to patients who do not obviously have pneumonia at the time the physicians saw them, and whose diagnosis was made only later. It seems obviously unfair to require physicians to be clairvoyant. The risks are that emphasis on the four hour rule, including payments made to physicians who fulfill the standard more often, will induce physicians to unnecessarily treat lots of patients with possible pneumonia with antibiotics in the hopes that some will turn out to have pneumonia, raising costs, causing side effects, and creating more antibiotic resistance. Thus, this data suggested how this particular performance measure was likely to have perverse effects.

Aggressive Glucose Lowering Treatment for Diabetes

The second article(3), published this month, addressed another well-known performance measure. This is the proportion of patients with diabetes mellitus who have hemoglobin A1C values less than 7%, as endorsed by the National Quality Forum and the National Committee on Quality Assurance.

Pogach et al retrospectively identified a cohort of patient with diabetes, then assessed the proportion of patients in this cohort who might not benefit from the application of the standard, because the results of the clinical research on which the standard was based might not apply to them. In particular, they identified patients with decreased life-expectancies or multiple or severe co-morbid conditions. Their criteria for identifying these patients were based on the exclusion criteria used by the major controlled trial of aggressive glucose reduction in patients with adult-onset diabetes, the UKPDS study. They found that 21.7% of their cohort had major co-morbid illnesses, 7.9% had major mental health problems, and another 4.4% had multiple co-morbid conditions, suggesting that 34.1% of the patients to whom the standard might usually be applied might not benefit from it. This is important because the aggressive control of diabetes needed to achieve a low hemoglobin A1C value at best only benefits patients by decreasing their risk of certain diabetic complications long term, but raises the risks of hypoglycemia (low blood sugar), which can be dangerous or fatal, for as long as treatment remains aggressive. The results of this study suggest that the performance measure could be applied to many patients who may never benefit from it, but would be at continuous risk of aggressive lowering of blood sugar. Again, this suggests how this performance measure might have perverse effects.

This article was accompanied by a pithy editorial by Rodney Hayward. Hawyard dissected problems with outcome-based performance measures that can lead to perverse results. Some of his observations particularly deserve quoting:

Readers may be perplexed as to why 2 new outcome measures lacking any risk adjustment were adopted. In truth, these new measures were a compromise between advocates of optimal goals (disease advocates) and advocates of simple, inexpensive performance measures (health plan leadership). Experts in evidence were not included in the compromise, which is part of the problem.

Payers, disease advocates, consumer groups, and political leaders are often dismissive of the complex reality of measuring care....

Wishful thinking will not transform poor performance measures into useful ones, and that well-meaning people have a profound aptitude for letting their desires and ideology blind them to unwanted facts and complexities that are so vexingly common in the real world.

Promoting optimal care using performance measures requires considering the very real tensions among treatment-related benefits and treatment-related burdens, risks, and costs. HL Mencken once said, 'for every problem, there is a solutiont that is simple, neat, and wrong,' and using unadjusted, 'all-or-nothin' optimal treatment targets as performance measures is such an example.

Some leaders in performance measurement have asked me, 'do you really think that these measures will lead clinicians and health systems to overtreat?' I am frankly amazed by this question. Spiraling healthcare costs and overtreatment are probably the defining feature of the US healthcare system. Industry-funded 'experts' and disease advocates have been effectively promoting overtreatment for decades, and performance measurement was supposed to be a tool to bring better value to healthcare spending. Although performance measurement has proved to be a very powerful took, like all tools it provides opportunities for both benefit and harm.

Again, as we have noted before, developing performance measures that will truly benefit patients will require detailed understanding of the clinical context, keen skeptical analysis of the available relevant research data, and careful balancing of benefits, harms and costs. All this would be very hard under the best of circumstances. But the continual attempts by those with vested ideological and financial interests to influence performance measures to advance their own interests make it unlikely that the whole P4P movement will have any good effects on patients.

The first improvement needed in the P4P movement is clear, detailed disclosure of all conflicts of interest affecting those involved in the movement at any stage.

At this point, patients and physicians should be very skeptical about who is likely to benefit from any new performance measure, particularly measures that are lavishly promoted.

Thursday, March 29, 2007

The pain at the University of Medicine and Dentistry of New Jersey (UMDNJ) just goes on and on. We have previously discussed, seemingly ad infinitum, the troubles there. The university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here).

New Jersey Senator Wayne Bryant, once one of the state's most powerful Democrats, was indicted today on corruption charges and accused of trading his political influence for a job at the state's medical university.

Bryant, 59, was charged in a 20-count indictment of engaging in a 'scheme and artifice to defraud the public of honest services.'

Bryant ... was accused by a federal monitor of directing millions of dollars to the University of Medicine and Dentistry of New Jersey after receiving a 'no-work' job there. R. Michael Gallagher, former dean at the medical university's school of osteopathic medicine, was also charged today in the indictment.

According to the indictment, Gallagher in 2003 gave Bryant the title of program support coordinator at the osteopathic school at a starting pay of $35,000 a year. The job helped Bryant accrue credit toward his state pension.

Bryant, according to the indictment, used his senate staff to arrange meetings for Gallagher with members of the Senate budget committee, at which Gallagher presented a 'white paper' regarding capital projects at the osteopathic school that needed funding. From 2003 to 2006, Bryant directed changes in the state budget to benefit the medical school, including an allocation of $2.325 million for the osteopathic school, the indictment said.

UMDNJ has become one of the most graphic examples of mismanagement of an academic medical institution. The case is also one of the most striking examples of the "anechoic effect." I have never found any reference to the troubles at UMDNJ in any article in a scholarly medical or health care, policy, or services research journal.

Failure to even talk about cases of bad or corrupt managment of health care institutions leaves us far from a solution to the problem.

Wednesday, March 28, 2007

In "Pharma Goes to the Laundry," Carl Elliott described Wyeth's marketing campaign for fenfluramine, the fen in the diet drug combination fen-phen. It included a stealth marketing effort, including strategically placed ghost-written articles on behalf of obesity as a public health problem. When reports of heart valve damage afflicting patients on fen-phen began to come out, the company allegedly tried to conceal the evidence it had supporting a causative role for the drug combination. [Elliot C. Pharma goes to the laundry. Hasting Center Report 2004: 34: 18-23, link here.] (See our post here.)

A few days ago, the New York Times reported how patients who developed valvular heart disease after taking fen-phen allegedly were then ripped off by their own lawyers.

W. L. Carter knew there was something fishy going on when he went to his lawyers’ office a few years ago to pick up his settlement check for the heart damage he had sustained from taking the diet drug combination fen-phen.

The check was, for starters, much smaller than he had expected. And his own lawyers threatened to retaliate against him if he ever told anyone, including his family, how much he had been paid. 'You will be fined $100,000, you will go to jail and you will be sued,' Mr. Carter recalled them saying.

Mr. Carter was right to have been suspicious. The lawyers defrauded their clients, a state judge has ruled in a civil case, when they settled fen-phen lawsuits on behalf of 440 of them for $200 million but kept the bulk of the money for themselves. Legal experts said the fraud might be one of the biggest and most brazen in legal history.

When the clients sued the drug maker, they agreed to pay the lawyers 30 percent to 33 percent of any money that was recovered, plus expenses. In this case, that would have left the 440 clients to divide perhaps $135 million.

But the clients received only $74 million. An additional $20 million went to a questionable 'charitable fund.' The rest — $106 million — went to lawyers. Though amounts of the individual settlements remain sealed, court papers suggest they were from $100,000 to $5 million. On average, plaintiffs received less than 40 percent of what the settlement agreement specified, instead of the roughly 70 percent to which they were entitled

At a hearing in 2002 ... the original judge in the case said ... [the lawyers] deserved the higher compensation 'for their services and for the incredible risks they took' and for 'the administrative headaches that came with that.'

But the judge who made that statement and who approved the settlement, Joseph F. Bamberger, received a financial benefit from the windfall. After retiring from the bench in 2004, Judge Bamberger became a director of the $20 million charity for a $5,000 monthly fee. He has since repaid what he received.

Judge Bamberger was reprimanded last year by the Judicial Conduct Commission in Kentucky. The commission said his actions were disturbing, inexcusable and shocking to the conscience.

Judge Bamberger acknowledged to the commission that he had approved fees and expenses of what he understood to be about 49 percent of the settlement but said he had not known about the contracts calling for payment of only 30 to 33 percent. He declined to comment for this article.

In August, the Kentucky Supreme Court suspended the three lawyers, finding that there was probable cause that they had misappropriated their clients’ money.

Some days, you just can't win. There seem to be two morals to this story. First, stealth marketing of and concealment of data about pharmaceuticals can have a cascade of bad effects on patients. Second, trying to solve such problems retrospectively through civil litigation can have its own bad effects. Instead, we need to better assure the honesty of clinical research data about and the marketing of pharmaceuticals (and devices) from the beginning.

Physicians need to be better watch-dogs in this regard on behalf of their patients.

Tuesday, March 27, 2007

Every time the issue of conflicts of interest affecting the US Food and Drug Administration (FDA) comes up, one is sure to see at least one opinion piece decrying how excess concern with such conflicts will stifle innovation and keep wonder drugs off the market. There seems to be a whole raft of economists, lawyers, and policy-wonks out there who believe that any slowdown in drug approvals or any excess concern about drug side-effects will lead to unmitigated disaster.

Recently, the FDA announced it would restrict physicians and scientists with major conflicts of interest from participating on its advisory boards. To summarize quickly (with quotes from a Washington Post article),

The biggest change bars anyone from serving on a committee who has a financial interest of $50,000 or more that could have an impact on the drug, device or other issue the committee is considering. Overriding this rule would require a special waiver. If such a waiver is granted, that person could attend meetings, consult and express his views, but could not vote.

In addition, anyone with a conflicting financial interest of less than $50,000 could sit on an advisory committee, but could not vote. There will be a 60-day comment period before the proposals take effect.

"The limit would cover financial interests over the proceeding 12 months and cover, for example, stock and consulting fees," [said an Agency spokesperson.]

See discussion of these changes on GoozNews and the links from PharmaGossip. I could easily argue that allowing people who get up to $50,000 a year from a drug company to sit on an advisory board would given undue influence to people who are paid substantial money by those with vested interests in having the board advise in a certain way.

Nonetheless, soon after these new rules were announced a commentary appeared in the Wall Street Journal aptly entitled "Drug Crazy," by Richard A Epstein, a law professor at the University of Chicago, which practically warned the sky would fall if people with large conflicts of interest are kept off FDA advisory boards. Here are some choice quotes.

The main justification for this new regime is the widespread perception that drug and device makers have "hijacked" the FDA process, allowing dangerous drugs to slip into the market. The most conspicuous illustration involves the various COX-2 inhibitors such as Vioxxand Bextra....

The common perception is that the FDA acted too late in removing these drugs from the marketplace, and indeed should never have approved them at all. That perception rests on a crucial tradeoff: how much of an increased risk of heart attack should people be allowed to run in order to mitigate the ravages of arthritis and other degenerative diseases.

'Suffering boomers want to fill Vioxx void' is a headline in last Friday's Chicago Tribune. The gist of the story: Baby boomers and others have returned to Pfizer's Celebrex, which reported an 18% increase in sales notwithstanding the FDA's stringent black box warning. Similarly, many individuals stashed away their Vioxx for a rainy day after it was recalled by Merck. These individuals understand the risk they're running, but trust their physicians to minimize its impact.

This evidence should put the FDA's zeal in a new light. Just how do these advisory committees 'protect' informed product users by limiting their choices for dealing with crippling chronic conditions?

The FDA's major problem is not laxity, but zealotry. Its current get-tough view on conflict of interest only aggravates the fundamental flaw in its institutional design. Transfixed on the harms drugs can cause, the FDA remains largely oblivious to the harms they can prevent. Any delay in the use of a successful drug is costly: The delay matters little to the FDA, but a great deal to the thousands who plea for compassionate exemptions to try a drug that has not met with FDA approval.

The current get-tough policy on conflicts of interest only magnifies these costly FDA biases. The agency rules cut out the persons who know most about the drugs, and who could well counter unsound objections by critical committee members. But keeping these experts off the committees also skews the deliberative process in a more subtle and powerful way.

Anyone who consults for drug companies is likely to come with the presumption that new drugs may well fill important therapeutic voids. Once these individuals, as a class, are kept off advisory committees, the remaining drug experts are more likely to have the populist views held by the likes of a Marcia Angell or Sidney Wolfe, who suspiciously view most new drugs as insignificant advances over prior treatments. I tremble at the thought that these "untainted" experts will markedly slow down the FDA approval process. This would be bad news for the tens of millions who suffer from arthritis, and the countless individuals who suffer from other conditions.

Right now, we all have a simple expedient to protect ourselves against dangerous drugs that make it to the market: Don't take them. But we have no protection at all when the FDA denies us that choice in the first place. Right now the pace of drug approval is too slow. We don't need the FDA to slow it up still further.

My response is, to be polite, oh, balderdash. Prof Epstein mainly succeeded in revealing his lack of knowledge about drugs and clinical epidemiology. Let me address his main points.

Did Taking Rofecoxib Off the Market Deprive Patients of a Uniquely Effective Drug?

His first major point is that removing Cox-2 inhibitors from the market deprives arthritis sufferers of some magically effective treatment.

To quote the latter study, "in terms of osteoarthritis efficacy, no statistically significant difference in PGADS scores was observed between the rofecoxib and naproxen groups over 12 weeks.... Improvement in AUSCAN scores was not statistically signifcantly different between the rofecoxib and naproxen groups." So even the authors of a Merck supported study were not claiming that Vioxx offered any more pain or symptom relief than did naproxen.

It is possible that for a few patients a Cox-2 inhibitor offers better symptom relief than a NSAID. But there is no evidence of any wide-spread or major advantages. The notion that Cox-2 inhibitors are better pain or symptom relievers seems to be an urban myth. And Counselor Epstein seems to have bought into this myth.

In fact, the only clear advantage of rofecoxib seemed to be that it lead to a slightly smaller risk of upper gastrointestinal (GI) problems than did traditional NSAIDs. For example, one study showed that the risk of upper GI bleeding was 1.3%/year for rofecoxib vs 1.8%/year for various NSAIDs. But even that is a small advantage. One would have to treat 200 patients with rofecoxib to avoid one such a bleed. See:Langman MJ, Jensen DM, Watson DJ et al. Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999; 282: 1929-1933. (link here)

Are the Risks of Drugs Well-Known, and Can be Easily Avoided by Not Taking Them?

Prof Epstein asserted that it is easy to avoid drug adverse effects. This might be true when these effects are well-known. But the whole point of the Vioxx case was that the adverse effects of rofecoxib were not well-known, and there were allegations that the adverse effects were concealed while the drug was vigorously promoted to a wide-spectrum of patients who were not at particular risk of GI side-effects, and could have been satisfactorily treated with other drugs. (See some relevant posts here, here, here and here.)

Do Conflicted Board Members Provide Needed Opposition to "Populists"?

The notion that without board members who are investors in or paid by pharmaceutical companies, boards will be lead by "populists" who "view most new drugs as insignificant advances over prior treatments." Underlying this is the unstated assumption that many drugs offer significant advances over prior treatments. This is why Prof Epstein "trembled" at the thought of any slow-down in drug approvals.

As a physician, I wish that most new drugs were major advances over existing treatments. But my knowledge of evidence-based medicine suggests that they aren't. Unfortunately, most new drugs (and most new treatments) offer at best only small incremental improvements over other relevant options. And some are simply "me-too" efforts that really offer the most inconsequential advantages.

For example, see the data presented on Vioxx (rofecoxib) above. Clinical research never showed that this drug was a much better pain or symptom reliever than old-fashioned NSAIDs. At best, it lead to slightly fewer gastrointestinal side effects. But we now know that these were traded for increased risk of adverse cardiovascular effects.

In summary, I would suggest that lawyers and economists who write about drugs ought to look at the relevant clinical research before composing their first sentences. Maybe that would give them a more realistic idea of what new drugs and other health care products really are innovations, and what their downsides might be.

By the way, the author of the article, Richard Epstein, did disclose that he has "consulted frequently with pharmaceutical companies." Maybe employment by these companies influenced him to be less than skeptical about the benefits and harms of their products.

Saturday, March 24, 2007

Blue Cross of California 'routinely' violated state law when it canceled individual health insurance coverage after policyholders got pregnant or sick, making no attempt to determine whether they did anything to merit such "harsh" treatment, according to a state investigation of practices that appear to be industrywide.

As a result of its unprecedented investigation, the Department of Managed Health Care on Thursday said that it had fined Blue Cross $1 million — an amount immediately criticized by canceled policyholders and consumer advocates as too small to matter to an insurer whose parent company, WellPoint Inc., earned $3.1 billion in profit last year on revenue of $57 billion.

Indianapolis-based WellPoint disputed the findings, saying it acted legally and that some rescissions are necessary to combat fraud.

The state investigation found that Blue Cross used computer programs and a dedicated department to systematically investigate and cancel the policies of pregnant women and the chronically ill regardless of whether they intentionally lied on their applications to cover up preexisting medical conditions — a standard required by state law for canceling individual policies.

Regulators examined 90 randomly selected cases of policy cancellations — out of about 1,000 a year in California — and found violations in each one.

'This looks like 'Rescission Inc.,' ' said Bryan Liang, director of the Institute of Health Law Studies at California Western School of Law in San Diego. 'It's clear if 100% of these individuals had their policies illegally pulled, that means that there's a problem. These are just the tip of the iceberg.'

What sort of insurance is it when the policy can be cancelled as soon as its holder makes a large claim, on the pretext that in retrospect something the policy-holder wrote on a complicated and hard to interpret application form was wrong?

Note that we most recently wrote about charges that the California Blue Cross unit of WellPoint was cancelling policies in this manner here.

Note also that this is the same WellPoint whose New York Empire Blue Cross and Blue Shield subsidiary recently misplaced a computer disc containing confidential information on 75,000 policy-holders (see story here).

Furthermore, this is the same WellPoint which settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see story here).

Finally, this is the same WellPoint whose retiring CEO earned more than $8.5 million in total compensation in 2005, and will be receiving a lump sum retirement payment of $31 million when he steps down (see story here).

At WellPoint, we are dedicated to improving the lives of the people we serve and the health of our communities. From the boardroom to the mailroom, every associate is expected to honor the company's commitments to our diverse customers, fellow associates, shareholders and the communities we serve - helping us become the most trusted choice among consumers.

Our business strategies mirror our commitment to providing affordable quality care to our members and the public. In line with our vision to become the most valued company in our industry, we must:

* Bring affordable quality health care and coverage to medically underserved communities* Educate people to take an active role in their own health* Work with our health care partners to improve quality of care* Help shape public policy that makes health care more affordable and more accessible

Say what? WellPoint is a for-profit company. Its first obligation is supposed to be to make money for its share-holders. I won't comment on how successful it has been in that regard. It certainly has been successful in putting money in the pockets of its out-going CEO.

But how does a "commitment" to provide "affordable quality health care" square with cancelling individual subscribers who actually need to the insurance to pay medical bills? How does a "commitment" to "work with our health care partners to improve quality of care" lead to settling a RICO law-suit about withholding physicians' reimbursement?

It's funny how for-profit managed care organizations warm and fuzzy statements of purpose seem to contrast with how they operate in real life (see also the case of UnitedHealth's recent advertising here).

Maybe soon they will be retailing bridges across the East River in New York.

Friday, March 23, 2007

A number of important and interesting stories have lately been perspicaciously covered by some other bloggers. I think we are starting to demonstrate that blogging can help spread the word about important cases of health care mismanagement, conflicts of interest, and malfeasance, and of cases of attempts to promote pseudoevidence by deception and intimidation, the sorts of cases which used to only get local coverage. "Sunlight is the best disinfectant."

On PharmaGossip, the latest pharmaceutical marketing bomb-shell, pharmaceutical representatives moon-lighting in beauty pageants. This is a useful link to look at the next time someone in pharmaceutical marketing argues that drug detailing is all about presenting physicians with the most relevant evidence in a sober and scientific manner.

On the Clinical Psychology and Psychiatry Blog, how a pharmaceutical company tried to deal with a scientific presentation suggesting one of its products might be more hazardous that was previously thought. The methods contemplated included trying to stop or delay publication of the paper, possibly by exerting "influence" on the editorial board, or article reviewers. This is another nasty reminder about how marketing may trump science, and patient welfare in some health care organizations.

Also on the Clinical Psychology and Psychiatry Blog, how some US state Medicaid programs are using pharmaceutical company subsidiaries to try to control drug utilization, including of that company's products. This appears to be a new variant of hiring the fox to guard the hen-house.

On the [anti-] Scientific Misconduct Blog, a discussion of the ad hominem attacks that have been launched against one of the more important medical whistle-blowers of the last decade, Dr Nancy Olivieri. Such attacks, of course, should not diminish the importance of the case of attempted research suppression that she made public.

And speaking of leaders of health care organizations who will not tolerate dissent...

The Associated Press (here via SFGate.com) reported that although Dr Andrew von Eschenbach, the new chief of the US Food and Drug Adminstration (FDA) vowed during a congressional hearing to protect "the legal rights of every single employee within the FDA," he seemed to have a rather harsh view of any FDA employee who might speak out publicly in opposition to the party line.

However, during a June 2006 meeting, von Eschenbach told a group of 30 to 40 employees that anyone who went against the "team" could end up being "traded," according to accounts by agency whistle-blowers, including Dr. David Ross.

During Thursday's hearing, von Eschenbach apologized to Ross, who now works for the Department of Veterans Affairs, if his comments had been misunderstood. The FDA head then told lawmakers he wanted to foster an environment — 'if you will, a locker room' — where people with diverse points of view and different perspectives could debate, vigorously and aggressively, any problems or issues.

Ross said in February that he left the FDA 'rather than be silenced.'

Von Eschenbach went on to add: 'When people don't choose to participate in that and aren't willing to be a part of that and simply express opinions independent of that, I don't think that's helpful to the process.'

Ross told reporters during a break in Thursday's hearing that that qualifying statement 'sends a very unfortunate message.'

Unfortunately, this is all too parallel with how dissent appears to be treated at the CDC (see post here). Again, in my humble, a scientifically-based agency whose task is to protect the health of the public requires the same sort of spirit of free enquiry that is part of the academic mission (but often only honored in the breach on campus). For the leadership of such an agency to regard independent opinios as not "helpful to the precess" is to acknowledge, once again, mission-hostile management.

We have previously posted (most recently here) about allegations of mismanagement at the US Centers for Disease Control and Prevention (CDC).

The Atlanta Journal Constitution just reported an unusual exchange between Dr Julie Geberding, the head of the CDC, and US Senator Charles Grassley, the senior Republican on the US Senate Finance Committee. It seems that Senator Grassley requested a briefing from the newly hired CDC ombudsmen, but Dr Geberding refused the request.

In a March 5 letter to Grassley, Geberding said the two contract employees the CDC has hired to serve as interim ombudsmen believe that briefing the senator would violate standards of practice for ombudsmen and render them unable to continue to do their jobs effectively.

'While I am respectful of your desire to get further information, I am also sensitive to these principles — especially because CDC's Ombudsman Office is in a critical stage of development,' Gerberding wrote.

The big problem with that argument is that the ombudsmen already had agreed to brief Geberding.

Grassley's letter questions the validity of the ombudsmen's reasoning, stating that he is neither the subject of the ombudsmen's inquiries 'nor a potential cause of employee angst at CDC.' He notes that the ombudsmen have met and briefed Gerberding. Many employees blame Gerberding and her leadership for problems at the agency.

'Dr. Gerberding, am I missing something here?' Grassley asked in his letter. 'Why would two individuals claim preserving their objectivity as Ombudsmen requires refusing to brief Congress, but allows meeting with you to discuss their findings?' Grassley wrote, adding that he's not surprised that few CDC employees have 'felt comfortable approaching these two men to seek their help on their problems with CDC management.'

In my humble opinion, it's a funny sort of ombudsman who reports to the leader of his or her government agency, but cannot report to Congressional oversight. I would imagine any half-way rational CDC employee would be very hesitant to say anything to the ombudsmen that might be the slightest bit offensive to the leadership of the CDC.

Thus, the CDC still appears to be an agency whose leadership does not easily tolerate criticism. Given the scientific basis of the agency, this would appear to be yet another example of mission-hostile management, US government agency style.

But it seems that in many kinds of health care organizations, not just in the US, not just government agencies, the worst sin is to criticize the management. Given the ineptness, and worse of the management of many health care organizations (some of which has been featured on Health Care Renewal), is it any wonder that health care is in a mess?

Wednesday, March 21, 2007

We have written extensively about physicians' and health care leaders' financial entanglements with other health care organizations. This week, several important articles providing new insights into this problem appeared.

First, the Journal of the American Medical Association, (JAMA) published an article about pharmaceutical payments to physicians in two states. [Ross JS, Lackner JE, Lurie P et al. Pharmaceutical company payments to physicians: early experience with disclosure laws in Vermont and Minnesota. JAMA 2007; 297: 1216-1223. ] Vermont and Minnesota, as well as several other states, have laws in place requiring pharmaceutical companies to report payments made to physicians for a variety of purposes, and the information from these reports is supposed to be made public.

The main lesson from this study was that problems with the laws and how they were operationalized meant that the data they provided about financial interactions between physicians and the pharmaceutical industry was very incomplete. Ross and colleagues only were able to get access to some of the pharmaceutical companies' reports, and with considerable difficulty. It took considerable negotiation to obtain computerized information from Vermont. Minnesota's records were available, but only in the form of paper forms that the investigators had to laboriously copy. Then they found that considerable data was missing or incomplete. Some companies failed to provide any data during particular years. The Vermont data was linked to specific payment recipients in only a few instances. Finally, it turned out that Vermont allowed companies to withhold information about payments to physicians as "trade secrets."

Even so, what data was available suggested that considerable numbers of physicians have substantial financial interactions with pharmaceutical companies. Based on the Minnesota data, which provided information about individual recipients, 14% of physicians with active medical licenses received payments from pharmaceutical companies of at least $100. Although the median number of payments to individual physicians was one, the range was from 1 to 88. the median amount was $1000, but the range was $100 to $1,178,203.

The JAMA article was accompanied by a commentary [Brennan TA, Mello MA. Sunshine laws and the pharmaceutical industry. JAMA 2007; 297: 1255-1257.] Note that one author, Dr Brennan, is currently a full-time executive with a commercial managed care organization, Aetna Inc. Nonetheless, the commentary provided some important summary points.

What these investigations have found is discouraging. First, numerous payments to physicians exceeded the $100 limit that has been suggested by the American Medical Association. Because this amount was also endorsed by the major pharmaceutical industry trade group, the finding undermines faith in industry self-regulation. Second, and worse, there are many holes in the reporting.

Nonreporting undermines hospitals' and medical societies' own efforts to police conflicts of interest among physicians.

Most importantly, efforts to circumvent the law make the drug companies look silly at best and arrogant at worse. To call small payments to individual physicians 'trade secrets' or offer 'doctor' as the name of a recipient can only create mistrust.

To be clear, for-profit industries do not share the same ethical norms to which physicians and other health care professionals must adhere. Their primary commitment is to create shareholder value, not maintain an altruistic commitment to patients. But at some point the leadership of the pharmaceutical industry and their boards of directors must begin to recognize that growing public and professional mistrust could substantially detract from that value.

Finally, the New York Times did its own analysis of the Minnesota data. It focused on a few academic physician leaders who had substantial financial entanglements with the pharmaceutical and biotechnology industry. First, Dr Allan Collins:

Dr. Allan Collins may be the most influential kidney specialist in the country. He is president of the National Kidney Foundation and director of a government-financed research center on kidney disease.

In 2004, the year he was chosen as president-elect of the kidney foundation, the pharmaceutical company Amgen, which makes the most expensive drugs used in the treatment of kidney disease, underwrote more than $1.9 million worth of research and education programs led by Dr. Collins, according to records examined by The New York Times. In 2005, Amgen paid Dr. Collins at least $25,800, mostly in consulting and speaking fees, the records show.

In an e-mail message, Dr. Collins said he personally received in 2004 less than $10,000 from Amgen for educational presentations. 'The contract amount of $1.9 million from Amgen was paid to the Minneapolis Medical Research Foundation (MMRF) for the research contract, on which I am the designated senior researcher,' Dr. Collins wrote. He wrote that he did not work for or serve on the board of directors of the foundation. Dr. Collins discloses on his Web site and research papers that he is a consultant to Amgen, among other companies.

Dan Whelan, an Amgen spokesman, said the company paid the Minneapolis Medical Research Foundation 'to conduct sophisticated research and data analyses that have enhanced the understanding of health care delivery' for kidney patients.

Then Dr Richard Grimm

This list of top doctors in Minnesota includes Dr. Richard Grimm of the Berman Center for Outcomes and Clinical Research in Minneapolis, who has twice served on government-sponsored hypertension panels that create guidelines about when to prescribe blood pressure pills. Last year, he served on a National Kidney Foundation panel that wrote guidelines about when kidney patients should be given cholesterol pills.

Between 1997 and 2005, Dr. Grimm earned more than $798,000 from drug companies, according to records. In 2003 alone, Pfizer paid Dr. Grimm more than $231,000. Pfizer markets Lipitor, a cholesterol drug that last year had $12.9 billion in sales, more than any other drug in the world. It also markets Norvasc, a hypertension drug that last year had $4.9 billion in sales. Guidelines that suggest greater use of these drugs would be a huge boon to Pfizer.

'Drug companies are like lions,' Dr. Grimm said of his sponsored talks. 'For lions, it’s their nature to kill zebras and eat them. For drug companies, it’s their nature to make money. They’re not really trying to improve anybody’s health except if it makes them money.'

'On your side, you’re making a bit of money, but you’re also trying to educate the doctors. And in my view, the doctors need a lot of educating.'

Finally, Dr Donald Hunninghake:

Dr. Donald Hunninghake served on a government-sponsored advisory panel that wrote guidelines for when people should get cholesterol-lowering pills. The panel’s 2004 recommendations that far more people get the drugs became controversial when it was revealed that eight of nine members had financial ties to drug makers. The full extent of those ties have never been revealed.

In 1998 alone, Pfizer paid Dr. Hunninghake $147,000, and he earned at least $420,800 from drug makers between 1997 and 2003. He left the University of Minnesota in 2004 to become a full-time industry consultant. He is now retired.

'Most of my talks did not relate to drugs but the guidelines for treatment,' Dr Hunninghake said.

The Times article also quoted a number of critics of the financial relationships between drug companies and some doctors and academic medical leaders.

'When honest human beings have a vested stake in seeing the world in a particular way, they’re incapable of objectivity and independence,' said Max H. Bazerman, a professor at Harvard Business School. 'A doctor who represents a pharmaceutical company will tend to see the data in a slightly more positive light and as a result will overprescribe that company’s drugs.'

And,

'The vast majority of the time that we did any sort of paid relationship with a physician, they increased the use of our drug,' said Kathleen Slattery-Moschkau, a former sales representative for Bristol-Myers Squibb and Johnson & Johnson who left the industry in 2002. 'I hate to say it out loud, but it all comes down to ways to manipulate the doctors.'

Jamie Reidy, a drug sales representative for Pfizer Inc. and Eli Lilly & Company who was fired in 2005 after writing a humorous book about his experiences, said drug makers seduced doctors with escalating financial inducements that often start with paid trips to learn about a drug.

'If a doctor says that he got flown to Maui, stayed at the Four Seasons — and it didn’t influence him a bit? Please,' Mr. Reidy said.

The lectures earn doctors more than cash.

'You’re making him money in several ways,' said Gene Carbona, who left Merck as a regional sales manager in 2001. 'You’re paying him for the talk. You’re increasing his referral base so he’s getting more patients. And you’re helping to develop his name. The hope in all this is that a silent quid quo pro is created. I’ve done so much for you, the only thing I need from you is that you write more of my products.'

A few of the doctors who took drug company money admitted it was for marketing purposes.

Drug companies 'want somebody who can manipulate in a very subtle way,' said Dr. Frederick R. Taylor, a headache specialist in Minneapolis who earned more than $710,000 between 1997 and 2005, much of that from GlaxoSmithKline, the maker of the migraine drug Imitrex.

Dr. George Realmuto, a psychiatrist from the University of Minnesota, said most of the marketing associated with his lectures was packaged around his talks.

'It’s at a wonderful restaurant, the atmosphere is very conducive to a positive attitude toward the drug, and everyone is having a good time,' said Dr. Realmuto, who compared the experience to that of buying a car in a glitzy showroom. He earned at least $20,000 between 2002 and 2004 from drug makers.

As the man says, read the (several) whole things.

These articles collectively add to our information about the pervasiveness of conflicts of interest within the health care system.

In summary, physicians or other health care academics who take money from drug (or biotechnology, or device or other health care) companies ought to disclose who paid them, how much, and for what whenever they speak, write, or otherwise attempt to communicate about any subject relevant to the companies' vested interests. Failing to do so means they are participating in deceptive marketing practices.

If disclosure might be uncomfortable, then perhaps that discomfort is saying something about the nature of the relationship created by the payments received.

A better solution might be for individual physicians and health care academic to forego all individual payments from commercial firms with vested interests related to the individuals' clinical and academic work. For this to work, of course, medical schools and academic medical centers would have to stop putting so much pressure on their faculty to bring in external funding, whatever the source, and whatever the ostensible reason, used by the institutions for whatever the purpose.

Meanwhile, physicians and the public need to look very hard to see if what people in academic medicine are saying is based on the their clinical and academic expertise, or their financial relationships with commercial firms with vested interests in having these communications come out a certain way.

Tuesday, March 20, 2007

Those who read the print version of the Wall Street Journal opened it yesterday (19 March) to find a full page advertisement from UnitedHealth Group, with a dramatic red background. The advertisement is not on the web, as far as I can tell, but its text is below:

The health care system isn't healthy. There's no denying it. A system that was designed to make you feel better often just makes things worse. Costs are out of control, access is inconsistent, quality is too variable and the entire process has become unwieldy.

Every day, more Americans are added to the rolls of the uninsured. This is an epidemic and it's time we found a cure.

At UnitedHealthcare, we are committed to improving the health care system. We aim to take what's wrong and make it right.> Simplifying everything and eliminating red tape.> Ensuring access to the right care anywhere in the U.S.> Empowering you to make better decisions about your health 24/7.> Providing information to doctors to better support people.> Rewarding first-rate physicians for first-rate medicine.

All while making your health care more affordable.

Will all this be simple? No. Simple doesn't mean simple-minded. Sometimes simple means ingenious. Sometimes it means revolutionary. And no one is better prepared to lead this revolution with you than the strongest, most commited health care company in the nation. Simpler process, smarter solutions, better results for you.

UnitedHealthcare Healing health care. Together.

Say what?

On one hand, the advertisement's statement of the problem in the first two paragraphs is hard to argue with, although it did leave out demoralized health care professionals as one of the primary manifestations of the problem.

The rest might be barely credible if UnitedHealth were a brand-new company.

Instead, it is a company that has been around a long time, and there are plenty of reasons to think that up to now it has been part of the problem, not the solution. UnitedHealth's claims about affordable health care are particularly suspect.

For example, we have discussed the amazingly generous compensation awarded to UnitedHealth's previous CEO, Dr William McGuire, at a time when the company's mission statement already included the goal of "making health care more affordable." Later, we discussed how McGuire had become more than a billionaire, at least on paper, due to the value of the stock options the grateful company bestowed upon him, while the company pursued an ever more concentrated health insurance market. Then it turned out that these stock options were back-dated (see post here), and McGuire was eventually forced to resign (see post here). Meanwhile, it turned out there have been allegations of conflicts of interest affecting the UnitedHealth board, and that at least one of the members of the board's compensation committee. Note that one member of that committee who had been most gushing in her support of McGuire and his outsized compensation was also the Dean of a major US nursing school (see post here).

Of course, McGuire has left, and so it's possible that UnitedHealth has changed its ways. But I should note that in the last few days, the American Medical Association is trying to block UnitedHealth's acquisition of Sierra Health Services Inc., charging that the acquisition would give UnitedHealth a near monopoly in the state of Nevada (see AP story via the Houston Chronicle); and here in Rhode Island, UnitedHealth is being criticized for trying to transfer a big chunk of profits out of state, given that it already spends less of its total revenue on actual health care than is typical (see story in the Providence Journal).

Monday, March 19, 2007

We have previously blogged (here and here) about ties among pharmaceutical companies and patient advocacy groups.

The Boston Globe just reported how a patient advocacy group was entangled with the pharmaceutical industry. The story was about Elzora K Brown, founder of the Breast Cancer Resource Committee:

Elzora K. Brown could stand before a microphone and calmly describe the swath of devastation that cancer has cut through five generations of her family.

"My own story is replicated in the lives of high-risk families across the globe," Brown told an audience of Food and Drug Administration advisers considering a controversial application to allow wider sales of silicon gel breast implants....

Brown's message about the need to reduce disproportionately high mortality rates among African-American women, like herself, resonated whether she was testifying before the FDA, addressing the nation's mayors, or speaking with members of Congress, where she was a staff assistant to former US House Majority Leader Jim Wright.

Through speaking engagements for the Breast Cancer Resource Committee, a patient-advocacy group Brown founded in 1989 , she highlighted the benefits of early cancer screening, offered a support group for African-American women, and called attention to the need for diversity among participants in clinical trials for new treatments.

Patient advocates like Brown regularly testify at FDA public hearings, packing an emotional punch as advisers vote on controversial drug and device approvals.

Although Brown's committee billed itself as an organization for patient advocacy, it was heavily supported by pharmaceutical company funds, and Brown herself made quite a nice living running it.

What few in Brown's audiences knew is that the patient advocate personally profited from her cancer-survival message, accepting funding from major pharmaceutical companies that produce cancer treatments, according to tax records.

'As a survivor, I want a healthy life after breast cancer, so the long-term side effects of treatment must figure into the treatment decision,' Brown said in a press release touting Ellence (epirubicin), a breast cancer drug that showed lower heart risk. The release, distributed by Pfizer Inc., did not disclose the funding that Brown's group received that year from the drug giant.

From 1996 to 2004 , the years for which Internal Revenue Service records are available, the Breast Cancer Resource Committee raised about $3.4 million from mostly corporate donors, including hundreds of thousands of dollars from such drug firms as Amgen Inc. , AstraZeneca Pharmaceuticals LP , GlaxoSmithKline PLC, and Pfizer Inc. As her nonprofit's coffers swelled, Brown's salary jumped from $40,100 to $162,500 --roughly one-third of every dollar raised. During that time, the group paid up to $2,600 a month for a four-story Washington, D.C., townhouse, assessed at $788,510 , where Brown lived and worked. She also made liberal use of the committee's American Express card for 'incidental, personal expenses,' according to tax records, leaving the balance unpaid.

The nonprofit's accountant, James Dunn , of White Hall, Md ., declined to respond to questions about liens the IRS filed against Brown in 2003 , which allege she underpaid taxes by $179,257 from 1997 to 2002.

Brown's highest salary was in 2002 , when she was paid $162,500 and the organization raised $554,993 . Brown's salary would have ranked her among the highest-paid chief executives for nonprofit advocacy groups of that size, according to a 2005 compensation survey of 1,660 nonprofits. It compares with a median salary of $72,000 paid to chief executives of nonprofit advocacy organizations with annual revenue from $500,000 to $1 million , according to Abbott, Langer & Associates Inc. , a firm that conducts salary surveys.

In 2002 , Brown also was reimbursed $37,246 for expenses and tallied $2,682 in personal charges on the committee's American Express card, according to the IRS filing. By 2004 , that unpaid card balance was $4,414.

The behavior of some groups ostensibly advocating for patients has drawn criticism.

Public Citizen's Peter Lurie , who testifies frequently before FDA panels, noticed a shift as public hearings 'were becoming contaminated by people who didn't represent the public in any way. They represented particular moneyed interests.' Lurie, deputy director of the consumer advocacy organization's health research group, said, 'It's a fair question: Who represents patients and how they come to call themselves' patient representatives?

The Globe interviewed others who were specifically critical of Brown.

'In a vacuum, Elzora Brown's salary is, arguably, not outrageous,' said Thomas A. McLaughlin , a consultant at Grant Thornton LLP and author of 'Streetsmart Financial Basics for Nonprofit Managers,' which coaches nonprofit leaders on how to read and use financial data. 'What is far less defensible is the fact that she is paid nearly one-third of every dollar that comes through the door.'

'It's looking like this is her own piggy bank,' said Daniel Borochoff , president of the American Institute of Philanthropy , a charity watchdog based in Chicago. 'You need to separate business and personal expenses; that's a pretty common principle.'

When patient advocacy groups are heavily funded by pharmaceutical companies that make products likely to be used by the patients the groups advocate for, and when the leaders of these groups are very well recompensed out of these funds, one wonders whether the groups' allegiance are first with patients or with their pharmaceutical company sponsors. At least they should disclose their sources of support and let their audience decide for themselves.

Saturday, March 17, 2007

We have posted several times, most recently here, about the controversy over the new system developed by the UK National Health Service (NHS) to select physicians for senior specialty training positions, part of the the new "Modernising Medical Careers" (MMC) program. Since the last post, criticism of the selection process, called the Medical Training Application Service (MTAS), has been growing. The Telegraph, which has been providing most of the coverage of this story, reported,

Prof John Bell, president of the Academy of Medical Sciences, and Prof Sir John Tooke, chairman of the Council of Heads of Medical Schools, criticised the scheme for undervaluing applicants' research experience and academic potential. In an open letter released yesterday, Prof Bell and Sir John said: 'Academic trainees - those doctors wishing to pursue careers which encompass research as well as patient care - have been particularly badly affected by the decision to anonymise applications and deprive the assessors of details of previous clinical and research experience. Without a scientifically informed and research-orientated medical workforce throughout the country, the Government's vision of the UK as a world-class centre for biomedical research and healthcare cannot be realised.'

Prof Ian Gilmore, the President of the Royal College of Physicians, added his voice to the criticism, saying the system was 'at the point of breaking down.'

Nine out of 10 doctors who have taken part in an online poll called for the resignation of those responsible for the MMC/MTAS debacle.

Meanwhile, The Lancet called for MTAS to be suspended and said the new system, combined with EU laws preventing junior doctors from working longer than 48 hours per week, would produce inexperienced consultants.

I am one of the lucky ones. I am here for one of the much coveted Medical Training Application Service (MTAS) interviews....

Any doctor awaiting an interview and hoping that the interview process will in some way be superior to the ludicrous, Kafkaesque application form should be warned: it isn't.

The grey man led me into a room filled with work stations manned by confused, bewildered looking interviewers. Some of them were doctors, some, I learned later, were not. None was properly introduced to me. It was clear they hadn't read my form and knew nothing about me. Each asked a series of formulaic questions to which I had a few minutes to provide equally formulaic answers.

There was no provision for me to discuss anything, to show my strengths and qualities, or to talk about the things that interest me. The bland questions were designed to elicit responses that could be ticked off on a form.

In all honesty, I wouldn't trust this system to select someone to water my plants, let alone look after me when I'm sick.

Dr Pemberton came to a clear realization what the larger problem is.

This is a clear attempt to undermine the medical profession; to ensure that we become compliant, unquestioning automatons in a system that can be presided over by managers and politicians.

He has hit the nail on the head. This seems to be the same problem that plagues us here in the US, and maybe plagues health care around the world.

When I interviewed physicians about what they thought was wrong with health care, many cited cases of bad decisions by, and conflicts of interest and outright corruption affecting health care leaders, who were often managers and politicians. Yet at the time, most of the physicians saw thess as their unique local problems, not as part of a largersystemic problem. Perhaps because physicians see the problems only as local, are too busy just trying to keep up with their patients' needs, or tend to be conflict-averse and apolitical, few physicians have protested the systemic problem. But maybe in the UK that is changing. Pemberton also wrote,

Doctors are notorious for being apathetic when it comes to fighting their corner. Not this time. We are so horrified by what is happening that there is now even talk of a strike.

In fact, doctors' protests were planned today in both London and Glasgow. The Telegraph reported on preparations for the London rally,

Speakers at the march in London and rally in Glasgow will call for the new online selection system, Medical Training Application Service (MTAS), to be suspended.

Andrew Lansley, shadow health spokesman, who will address the London march, says that MMC is 'an appalling shambles.'

'It risks undermining the morale and the future of the medical profession. What is the point of expanding medical school places and then destroying the career progression of juniors?'

'We cannot, we must not, abandon thousands of junior doctors; we must ensure that they can fulfil their vocation, for them and for our patients,' he said.

The junior doctors have increasingly been supported by senior doctors including some of the most eminent names in medicine.

The demonstrations have been organised by a grassroots doctors’ group, RemedyUK.

The BBC just reported that 200 doctors rallied in Glasgow today. And NHS Blog Doctor has a first report on the London march with some video. Maybe doctors in other countries should think about following their example. Grumbling to ourselves hasn't done much good.

A source told Brandweek that some of the 'biggest' drug companies had successfully placed "disease awareness" messages in reality TV shows. Non-branded mentions of diseases and conditions are useful to drug companies because they make patients more comfortable talking to their doctors about problems, and doctor visits lead to category-wide prescription sales increases.

Because the area is so controversial—no company wants to be scrutinized by the FDA—executives declined to say which brands were being placed.

The Nielsen statistics, however, imply that their efforts have paid off. There were 337 visual or audio mentions of prescription drug brands in 2006, according to Nielsen. That's up from 231 in 2005. The length of those occurrences also increased, from 607 seconds in 2005 to 1,548 seconds last year.

While a normal background level of drug mentions is to be expected—Viagra and Prozac are cultural touchstones as well as brands—some drug brands stick out in unusual ways.

Take, for instance, Dey Pharma's EpiPen, the injectible for people with potentially fatal allergic reactions. In the Jan. 16 episode of Boston Legal (ABC), a school teacher failed to administer the anti-allergy injectible to a child who ate peanut candy and died of anaphylactic shock.

The script read like an ad for the Dey brand: 'Anaphylactic shock can come on suddenly, which is what happened here,' said the boy's father, testifying on the show. 'If the EpiPen isn't administered, it can be fatal.'

EpiPen also was mentioned five times on the Feb. 8 episode of NBC's ER, per Nielsen.The Napa, Calif.-based Dey has previously denied that it engages in product placement. Last week, a source confirmed that when TV producers request branded props, the pharmaceutical company fulfills the requests.

The only drug company that has come out of the closet regarding product placement is Organon. In 2005, the Roseland, N.J., firm placed posters for its Nuvaring contraceptive in the backgrounds of NBC's Scrubs and CBS' King of Queens. Since then, it has added ABC's Grey's Anatomy to its list, according to brand director Lisa Barkowski.

And pharmaceutical company executives wonder why the public and physicians don't trust their companies? If they want to develop some trust, maybe they should start by plaining labeling every one of their marketing efforts as such.

Friday, March 16, 2007

We had posted a while back and again here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

This story, like those of other cases of research suppression and health care whistle-blowers, has not received a lot of press coverage, given their broad implications about the creation, as Wally Smith would call it, of pseudoevidence. To counter this version of the anechoic effect, Dr Blumsohn has his own blog, the Scientific Misconduct Blog, where he has posted updates on his ongoing efforts to get the word out about his dispute with Procter and Gamble and the University of Sheffield.

He just posted a fascinating new story. It seems that Dr Blumsohn submitted an abstract to The International Bone and Mineral Society (IBMS) Meeting (to be held in Montreal) which featured a re-analysis of some of the data of his original study of risedronate. This work failed to show a "plateau effect" in measures of bone resorbtion and fracture. The presence of such an effect was a point of contention between Dr Blumsohn and Procter and Gamble, and the failure to find such an effect did not help arguments the company was making in favor of risedronate.

At the bottom of the abstract, Dr Blumsohn noted that the study was funded by Procter and Gamble, as indeed was the original study from which this data which was re-analyzed had been derived. Blumsohn later received a message that one Dr Christopher Purple, of Medical & Technical Affairs, Procter & Gamble Pharmaceuticals had sent to the IBMS. Dr Purple, who has no known relationship to Blumsohn's study of risedronate, requested that the statement that disclosed support from Procter and Gamble be removed from the abstract. When the IBMS meeting staff learned they had been misled, they restored the funding disclosure statement.

This appears to be a new variant on ghost authorship, in which a ghost author managed temporarily to alter a manuscript without the knowledge of the manuscript's true authors. I have not previously heard of a case in which a disclosure statement was altered with the effect of erasing the support of a commercial sponsor for a project that did not turn out to provide data that fit that sponsor's vested interests.

Add this to the catalog of how pseudo-evidence is created. Add this also as a reminder that those who truly want to practice evidence-based health care need to heed this old Scottish poem:From ghoulies and ghosties,And long-leggedy beasties,And things that go bump in the night,Good Lord, deliver us!

An audit was done of the clinical IT project. At this location is a PDF of a Sacramento Business Journal article about the health IT problems and a believed massive overuse of consultants at UC Davis. (The audit report itself can be found at this link.)

A key observation is that "there's nothing to show why existing staff was not assigned to do what the university paid outside consultants $17 million to do."

Indeed.

I have stated that it is absurd to believe outsiders can know your business better than you, and it's even more absurd to believe it OK for outsiders to know your business better than you. While this pithy advice can be debated as a matter of strategy, I have also stated that healthcare IT is an experiment and a "work in progress" for the foreseeable future and that healthcare organizations need significant in-house expertise to keep up with the necessary changes, adjustments, modifications, extensions, interfaces, etc. that are a constant feature of this somewhat chaotic oil-and-water mix of IT and the "hiding in plain sight" complexities (a phrase coined by informatics researchers Nemeth & Cook) of clinical medicine. Heavily outsourcing these functions is unwise.

One can only speculate on the rationale for the $17 milllion of outsourcing, but "quid pro quo", behind-the-doors, golf-course handshake wheeling and dealing comes to mind as a possibility. Or perhaps it occurred due to a profound misunderstanding of what is tactical and what is strategic in healthcare IT.

The audit itself was somewhat superficial in scope, in that it excluded the product produced by the consultants and in sampling expenses used a time frame after the major consultant expenses incurred. It is interesting in that it showed that the project, due to be completed in December 2006 at $76 million, is only half done with current cost at $85 million. The audit alleges "no wrongdoing." You can be the judge of whether wrongdoing, mismanagement, or other ills affected this project.

In a sad footnote to this story, the outspoken health IT blog HISTalk had posted some of my commentary on this matter and on the former head of the health IT project at UC Davis. I had pointed out what I took as that person's lack of appreciation of the value of formally-trained medical informatics specialists based on my interactions with him a decade ago when he was a senior executive at Cerner. He confidentially negotiated with and hired a physician who was just finishing a postdoc at Yale's Center for Medical Informatics (which was certainly his right), where I was a faculty member with significant IT and management experience prior, while not wishing at all to speak to me and deflecting me to HR who gave me the traditional HR runaround (which was also his right, but I felt was revealing about strategic attitudes re: informatics expertise).

As a result of my HISTalk comments, I received the following unsolicited email from the former postdoctoral fellow -- a physician who I had helped select for the fellowship, and had always treated with the utmost respect and collegiality. This physician now runs his own obstetrics health IT company (just a year ago I had as a personal favor to him initiated referrals to several hospitals I thought might be interested in his company's products). Here is what he had to say:

From: DrMiller@eNATAL.com

Date: 01/06/2007 09:22PM

Subject: HISTalk

You are a horse's ass, and a pariah beyond rehabilitation. And I've tried on numerous occasions to help you get beyond your paranoid fantasies and fabrications (when no one else would even talk to you, much less be seen with you).

Almost every statement you wrote in HIStalk is either totally wrong or your own pufffed up delusions.

Don Miller

I pointed out to my former student that while those who "wouldn't talk to me" had reasons of their own making related to my ethics and temerity in actually defending myself against academic abuses, and while I admit I'm opinionated about MD's actually leading their profession and leading health IT via moving past stale business-computing-style thinking, I thought his message was way over the top and that apologies were due.

None came.

Healthcare IT is indeed still an area where angels should fear to tread.

Wednesday, March 14, 2007

Well, it's been a while, but the medical school at the University of California - Irvine (UCI) is back in the news. We had posted last year about various management problems at the same institution, involving its liver transplant service, cardiology division, and bone marrow transplant service, (see posts here and here) which lead the new chancellor of the campus to "acknowledge a failure of leadership and accountability" (see post here.) Slightly more recently, we noted the almost 20 year history of questionable financial relationships that involved one of UCI's "biggest stars" in clinical researach and several pharmaceutical companies (see post here).Last week, the Los Angeles Times reported about questionable relationships between the medical school and a local orthopedic practice.

UC Irvine's School of Medicine has hired an auditor to review the orthopedics department's finances in response to concerns about a contract with a private medical practice that has cost the school more than $1 million in lost revenue, UCI officials said.

The medical school entered into the contract with Mission Orthopedic Medical Associates and its well-known chief surgeon, Bernard Reimer, to help the school expand into the lucrative southern Orange County market, according to physicians in the orthopedics department.

But the contract immediately raised concerns among UCI's attorneys because of large sums paid up front to Reimer and his wife, Dawn, his office manager, which later triggered controversy within the department, according to UCI records obtained by The Times and interviews with UCI staff members.

'We are looking at things that don't make any fiscal sense,' said Dr. Ranjan Gupta, who took over as chairman of UCI's orthopedics department at the beginning of the year. 'I'm supposed to ensure that the university is giving the highest level of care and is getting the most for its money.'

The contract with Mission Orthopedic Medical Associates was negotiated in 2003 by Dr. Harry Skinner, then chairman of the orthopedics department, and Dr. Thomas Cesario, then dean of the medical school.

Skinner was forced to step down as department chairman in January. UCI had concluded he had made racially inappropriate comments to medical school employees. He remains on the faculty.

Cesario took early retirement late last year after an 11-year tenure marred by doctors stealing women's eggs and embryos, bodies missing from the medical school's willed-body program, and serious failings in the hospital's liver, kidney and bone marrow transplant programs.

In devising the contract with Mission Orthopedic, Skinner and Cesario agreed to cover part of the practice's overhead, pay Reimer's wife more than $100,000 to serve as its office manager, and give Reimer a place on the medical school faculty. In return, Reimer's patients would all be billed for their care through UCI Medical Center in Orange.

Both Reimer and his wife declined repeated requests for comment.

At the time the contract took effect, Reimer had been diagnosed with cancer and was working only part time, which enabled him to collect disability insurance payments, according to internal medical school e-mails and other records obtained by The Times.

He was eligible to receive insurance benefits as long as he earned no more than $100,800 a year, the UCI records show.

Skinner found ways to pay him for items other than salary to stay within that salary cap, the records show. For example, he agreed the university would pay Reimer and his wife $50,000 for attorney fees and an extra $10,000 a month for the first three months of his contract.

The Times also found that built into the overhead for the Mission Viejo office was a significant sum for Reimer's wife, the office manager. In addition to her $38,400 annual salary, Dawn Reimer received between $6,000 and $7,500 a month from UCI in additional payments described as 'general expenses,' the records show. As a result, UCI paid Dawn Reimer about $128,000 in 2005, more than what the school was paying her husband to treat patients, teach students and perform surgeries.

UCI's Credentials Committee placed Reimer on a list for "administrative termination" after noting that he had been on the faculty for more than a year without having been 'proctored,' a process in which a new faculty member's work is reviewed by a senior staff member.

The deal with Mission Orthopedic has been so expensive for the hospital that costs far exceed revenues from Reimer's patients, according to financial records reviewed by The Times.

As of the end of December, the losses were more than $1.2 million on total revenues of about $4.5 million over the previous three years and three months.

When all the numbers are tallied, expenses are expected to outstrip revenues by more than $1.7 million through June 2007.

As I noted the last time I posted about UCI...

It seems the more one looks, the more management problems one finds at the UCI medical school. This saga is another example of the complex financial relationships that pervade medical schools and academic medical centers. This recently revealed set of relationships is not about research or the pharmaceutical industry. However, it seems to be another demonstration that far too many leaders of health care organizations, including medical schools and academic medical centers, seem to have something other than the organizations' core mission in mind when making decisons.

Tuesday, March 13, 2007

A recent post inspired some discussion about physicians' reimbursement in the US. Last month, an article in the Annals of Internal Medicine offered a clear explanation about how the disparity in reimbursement between primary care (and other "cognitive") physicians and procedural specialists came to be, and why it is important. [Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306.]

Its main points were:

The widening income gap between primary care and other physicians correlates with declining interest in primary care.

Medicare's Resource-Based Relative Value Scale (RBRVS) system was advertised as a way to make reimbursement more equitable, and particularly fairer for primary-care, but it has had the opposite effect, for three main reasons

Proceduralists are often able to learn how to do their procedures more quickly, and thus increase the volume of procedures done, while office and hospital visits can only be sped up so much.

The process used to update the RBRVS system is biased towards procedures for three main reasons: 1. "specialty society influence in proposing RVU [relative value unit] increases," 2. the specialist-heavy RUC [Relative Value Scale Update Committee] membership," and 3. "the desire of RUC specialists to avoid increases in evaluation and management [that is, cognitive, or non-procedural] RVUs."

Medicare now uses a formula to limit increases in overall spending. The use of this formula leads to across the board cuts in all reimbursements. Since cognitive services reimbursements were never high to begin with, and have rarely been individually increased, these cuts tend to have disproportionate decreases.

Private insurers and managed care organizations tend to follow Medicare's lead in their reimbursement procedures, but tend to tilt the playing field even more in favor of procedures versus cognitive services. Several studies showed that such payers paid more for procedures than did Medicare, but about the same for office and hospital visits.

The authors concluded that "primary care practice is not viable without a substantial increase in resources available to primary care physicians." Yet primary care is an extremely important, albeit neglected part of the health care system. Most patients value "having a primary care physician who knew their medical problems." Furthermore, "patients with a regular generalist physician have lower overall costs than those without a generalist physician."

This article presents the clearest summary I have seen to date of what has gone wrong with the reimbursement of primary care and cognitive physicians in the US. (Although we have discussed Medicare's generally wooden-headed reimbursement system before, here. See also the Health Affairs article cited in that post for a more general discussion of why the system is wooden-headed.)

What is disturbing, although no reflection on the article's authors, is how long it has taken for someone to write about this problem. The RBRVS system has been going wrong since 1992. Managed care, which was supposed to come up with creative ways to control costs and improve quality, seems to have seen fit to simply ape Medicare's wooden-headed reimbursement for at least a decade. Meanwhile, primary care is slowly being throttled.

Of course, one reason it has taken so long to talk about it is doing so may threaten vested financial interests and settled ideological convictions. The justification for the first part of the assertion is obvious. Furthermore, the article is an indictment of government-run single payer health insurance, which may offend many on the left. After all, Medicare is such a single-payer system. The article also is an indictment of using the "competitive market-place" to control health care costs, which may offend many on the right. After all, managed care is supposed to be such a market-based solution.

Thus, let's see how many choose to continue to ignore the issues raided by Bodenheimer et al.

Instead, we should consider...

WHAT IS TO BE DONE -

1. If you are a primary care or cognitive physician, realize why your financial position is becoming untenable and stop feeling guilty about protesting an unfair system.

2. If you are a procedural specialist, realize that you are in the same boat as the primary care and cognitive physicians. If our part of the boat sinks, yours will not long stay afloat.

3. If you are a health care researcher, think about addressing this elephant in the living room which many of you have so long ignored.

4. All others, tell your political representatives that fair physician reimbursement and a viable primary care system are both worth having.

Contact Us

Email: info at firmfound dot org
or go to the web-site for FIRM - the Foundation for Integrity and Responsibility in Medicine

More About FIRM and Health Care Renewal

FIRM - the Foundation for Integrity and Responsibility in Medicine is a 501(c)3 that researches problems with leadership and governance in health care that threaten core values, and disseminates our findings to physicians, health care researchers and policy-makers, and the public at large. FIRM advocates representative, transparent, accountable and ethical health care governance, and hopes to empower health care professionals and patients to promote better health care leadership.

FIRM depends on contributions from individuals and non-profit organizations. FIRM does not accept any direct support from for-profit health care corporations.

FIRM welcomes support from individuals and non-profit organizations. If you are interested in donating to FIRM, please email info at firmfound dot org, snail mail us at 16 Cutler St, Suite 104, Warren, RI, 02885, USA, or see our web-site.

Subscribe To Health Care Renewal

Policies: Blog Roll and Comments

Our blogroll is meant to include blogs that provide interesting content relevant to what we write. It is not an endorsement in any way of any specific blog.

We accept comments, especially from registered Blogger users. If you do not wish to register with Blogger, we will accept anonymous comments, although prefer that they contain identification of the commenter.

We encourage thoughtful comments relevant to the issues brought up by the posts on Health Care Renewal.

All comments are moderated. We will reject spam, profanity, advertising of products or services not directly related to the content of this blog.

We will reject any unsubstantiated accusations or allegations.

Nonetheless, all comments represent only the opinions of those making them. The appearance of comments does not imply endorsement by the Health Care Renewal bloggers.

Please email general comments about the blog, other concerns, or questions to info AT firmfound DOT org